A phase 2 refractory CRC trial with the TAS-102/bevacizumab combo.

The first trial had a median follow up of 10 months with 47 patients in the TAS-102 arm and 46 patients in the TAS-102/bevacizumab arm. In the combo mPFS was 4.6 months and mOS was 9.4 months.

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From Aug 24, 2017, to Oct 31, 2018, 93 patients were enrolled and randomly assigned to TAS-102 (n=47) or TAS-102 plus bevacizumab (n=46). The clinical cut-off date was Feb 15, 2019, after a median follow-up of 10·0 months (IQR 6·8-14·0). The most frequent grade 3 or worse adverse event was neutropenia (18 [38%] of 47 in the TAS-102 monotherapy group vs 31 [67%] of 46 in the TAS-102 plus bevacizumab group). Serious adverse events were observed in 21 (45%) patients in the TAS-102 group and 19 (41%) in the TAS-102 plus bevacizumab group. No deaths were deemed treatment related.

Median progression-free survival was 2∙6 months
(95% CI 1∙6–3∙5) in patients receiving TAS-102
monotherapy and 4∙6 months (3∙5–6∙5) in patients
receiving TAS-102 plus bevacizumab (HR 0∙45, 95% CI
0∙29–0∙72; p=0∙0010

Median overall survival was 6∙7 months (95% CI
4∙9–7∙6) in patients receiving TAS-102 monotherapy and
9∙4 months (7∙6–10∙7) in patients receiving TAS-102 plus
bevacizumab (HR 0∙55, 95% CI 0∙32–0∙94; p=0∙028

Disease control (complete or partial response or stable
disease according to RECIST 1.1) was reported in 24 (51%)
patients in the TAS-102 monotherapy group and 31 (67%)
patients in the TAS-102 plus bevacizumab group
(p=0·14). One patient in the TAS-102 plus bevacizumab
group had a partial response. No patient in the TAS-102
group had a partial response.
https://sci-hub.ru/10.1016/S1470-2045(19)30827-7

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